Practical Anemia Bundle for SusTained Blood Recovery (PABST-BR)

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Anemia; Critical Illness

Treatments: Drug: Iron Dextran; Drug: Erythropoietin (EPO)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05167734

21-006511

K23HL153310-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to test a multi-faceted anemia treatment plan to reduce the severity of anemia and to promote hemoglobin and functional recovery in adults who have been in the intensive care unit (ICU).

Full description

Anemia is common during critical illness and is associated with impaired outcomes during and after hospitalization. The goal of this investigation is to test a multi-faceted anemia prevention and targeted treatment bundle to attenuate anemia development and promote functional recovery in the setting of critical illness. Specifically, this will be a pragmatic phase II clinical trial of a multi-faceted anemia prevention and treatment bundle with 3 aspects (optimized phlebotomy practice, clinical decision support, targeted pharmacologic anemia treatment) assessing the impact of the intervention on hemoglobin concentrations (primary aim), transfusion utilization, and functional outcomes through 3 months after hospitalization.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of signed and dated informed consent form (may be completed by legal proxies for those patients unable to provide consent, i.e. sedation/intubation)
• Stated willingness to comply with all study procedures and availability for the duration of the study, including follow-up assessments
• Current ICU admission at Mayo Clinic Rochester with anticipated ICU duration >48 hours after enrollment
• Current ICU duration < 7 days
• Patients embedded in the local or regional Mayo Clinic Health System to facilitate post-hospitalization outcome assessment
• Moderate-to-severe anemia (i.e. hemoglobin concentration < 10 g/dL) at the time of enrollment, with the hemoglobin concentration assessed no more than 24 hours prior to enrollment. If RBC transfusion has been administered between the qualifying hemoglobin assessment and enrollment, a repeat hemoglobin will be required prior to enrollment to ensure that it remains < 10 g/dL.

Exclusion criteria

• Recent or current IV iron or erythropoiesis stimulating agent (ESA) use (i.e. darbepoetin, Aranesp, erythropoietin, Epogen, Procrit, Retacrit) within 30 days of enrollment
• Severe anemia prior to hospitalization (i.e. hemoglobin <9 g/dL within 90 days of admission)
• Known allergic reactions to iron or EPO
• Inability to complete outcome assessments (i.e. not expected to survive hospitalization, unable to make follow-up appointments, non-ambulatory, dementia or other severe cognitive impairment, visual impairment i.e. blind or legally blind)
• Pregnancy or breastfeeding at time of enrollment
• Inability to receive pharmacologic venous thromboembolic prophylaxis except in patients with recent surgical or gastrointestinal bleeding
• Active or suspected thrombosis (i.e. deep venous thrombosis, pulmonary embolism, acute arterial thrombus within 3 months)
• Uncontrolled sepsis (i.e. <48 hours of appropriate antimicrobial therapy and/or lack of definitive source control)
• Having received ≥10 units of allogeneic RBCs in the 48 hours before enrollment
• Acute coronary syndrome or ischemic stroke within 3 months
• Weight less than 40 kg
• Concerns with study enrollment expressed by the clinical team
• Mechanical circulatory support devices

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Control (Standard of Care) Group

No Intervention group

Description:

Subjects will receive standard clinical care for the treatment of anemia while in the ICU.

Anemia Treatment Bundle

Experimental group

Description:

The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).

Treatment:

Drug: Erythropoietin (EPO)

Drug: Iron Dextran